Imageguided Theranostics in Multiple Myeloma

NCT02403102 | Completed

• 1 other identifier: 15/LO/0036 CCR4236
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Theranostics is the use of a diagnostic test to decide which patients will benefit from a certain treatment. The current standard treatment for patients with myeloma is induction chemotherapy followed by peripheral stem cell transplant. Although there are options for timing of treatments, patient outcomes are variable and the investigators do not currently know which patients benefit from which treatment schedule. There is evidence to suggest that residual disease on imaging after treatment is an indicator for a worse prognosis, however the best time point for this imaging is currently not known. This study is designed to show if there is an optimum time point for correlation between imaging and prognosis. Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and the investigators will confirm this when patients are first diagnosed, by performing both FDG PET/CT and whole body diffusion weighted MRI. Patients will then be followed up with whole body diffusion weighted MRI after induction chemotherapy and 3 months post autograft. The investigators will look at the amount of disease present on these scans and correlate this with outcomes. There are likely to be other factors which influence patient outcomes (such as genetics) and the investigators will also look at some of these. Patients who undergo autograft have regular blood tests and marrow samples taken as part of routine care, the investigators will use some of these samples (without compromising the patients treatment) to analyses some of these other factors. If the investigators are able to determine a correlation of genetic factors with outcome this information could be used in future research. Theranostics is the use of a diagnostic test to decide which patients will benefit from a certain treatment. The current standard treatment for patients with myeloma is induction chemotherapy followed by peripheral stem cell transplant. Although there are options for timing of treatments, patient outcomes are variable and the investigators do not currently know which patients benefit from which treatment schedule. There is evidence to suggest that residual disease on imaging after treatment is an indicator for a worse prognosis, however the best time point for this imaging is currently not known. This study is designed to show if there is an optimum time point for correlation between imaging and prognosis. Several studies have indicated that MRI is better at detecting disease than FDG PET/CT and the investigators will confirm this when patients are first diagnosed, by performing both FDG PET/CT and whole body diffusion weighted MRI. Patients will then be followed up with whole body diffusion weighted MRI after induction chemotherapy and 3 months post autograft. The investigators will look at the amount of disease present on these scans and correlate this with outcomes. There are likely to be other factors which influence patient outcomes (such as genetics) and the investigators will also look at some of these. Patients who undergo autograft have regular blood tests and marrow samples taken as part of routine care, the investigators will use some of these samples (without compromising the patients treatment) to analyses some of these other factors. If the investigators are able to determine a correlation of genetic factors with outcome this information could be used in future research.

Conditions

Cancer; Myeloma

Keywords

Magnetic Resonance Imaging; Myeloma; Autograft

Outcome Measures

Primary Outcomes (1)

• Construct a ROC curve and calculate area under the curve (AUC) to show that the burden of disease at 3 months post autograft (WB-DWI score) is predictive of disease status at 2 years.

  2 years post autograph

Secondary Outcomes (4)

• Use multivariate/univariate analysis to identify the best single or combination MRI parameter(s) to predict disease status at 2 years

  2 years post autograph

• Identify optimal cut-off point with best sensitivity and specificity to predict disease status at 2 years.

  2 years post autograph

• Calculate PFS for patients grouped by optimal cut-off.

  2 years post autograph

• Overall survival (OS) in patients with residual disease on WB-DWI post induction and 3 months post autograft.

  2 years post autograph

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with myeloma planned for autograft.

You may qualify if:

• All patients over the age of 18 with multiple myeloma planned for autograft.

You may not qualify if:

• MRI incompatible metal implants
• Claustrophobia
• Diagnosis of other malignancy within 5 years.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Cancer Research UK: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Messiou C, Porta N, Sharma B, Levine D, Koh DM, Boyd K, Pawlyn C, Riddell A, Downey K, Croft J, Morgan V, Stern S, Cheung B, Kyriakou C, Kaczmarek P, Winfield J, Blackledge M, Oyen WJG, Kaiser MF. Prospective Evaluation of Whole-Body MRI versus FDG PET/CT for Lesion Detection in Participants with Myeloma. Radiol Imaging Cancer. 2021 Sep;3(5):e210048. doi: 10.1148/rycan.2021210048.

  PMID: 34559006 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Patients who undergo autograft have regular blood tests and marrow sampling and we will use these samples, to look at other factors which influence patient outcomes such as genetics, without compromising routine care. Some of the genetic tests performed on the bone marrow are not routine so we will obtain additional consent to do this.

MeSH Terms

Conditions

Neoplasms; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type

Study Officials

• Christina Messiou, Dr

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Imaging

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 31, 2015
• Study Start: March 26, 2015
• Primary Completion: February 1, 2021
• Study Completion: February 28, 2021
• Last Updated: December 14, 2022

Record last verified: 2021-05

Locations

GB (1)